Safety and Efficacy of Specially Designed Texture-Modified Foods for Patients with Dysphagia Due to Brain Disorders: A Prospective Study

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Safety and Efficacy of Specially Designed Texture-Modified Foods for Patients with Dysphagia Due to Brain Disorders: A Prospective Study
healthcare
Article
Safety and Efficacy of Specially Designed Texture-Modified
Foods for Patients with Dysphagia Due to Brain Disorders:
A Prospective Study
Soyoung Kwak, Yoo Jin Choo                    , Kyu Tae Choi and Min Cheol Chang *

                                          Department of Physical Medicine & Rehabilitation, College of Medicine, Yeungnam University, Daegu 42415,
                                          Korea; sk315@ynu.ac.kr (S.K.); cyj361@hanmail.net (Y.J.C.); choi3190@ynu.ac.kr (K.T.C.)
                                          * Correspondence: wheel633@gmail.com; Tel.: +82-53-620-3270

                                          Abstract: Providing texture-modified food for patients with dysphagia is a cornerstone of dysphagia
                                          treatment. This study aimed to evaluate the safety and efficacy of a specially designed texture-
                                          modified food that can be easily swallowed while maintaining the unique taste by adjusting hardness
                                          and adhesiveness in patients with brain disorders using a videofluoroscopic swallowing study. We
                                          included 101 patients with oropharyngeal dysphagia due to brain disorders who were referred to the
                                          rehabilitation department. To evaluate the safety and efficacy of a specially designed texture-modified
                                          food, rice gruel was compared with a regular instant rice porridge, and bulgogi mousse was compared
                                          with ground bulgogi, which normally serves as a texture-modified diet for patients with dysphagia in
                                          our hospital during the videofluoroscopic swallowing study. The Penetration–Aspiration Scale score,
                                          oropharyngeal transit time, number of swallows required to maximally eliminate food materials
         
                                   from the oropharyngeal space, and vallecular and pyriform sinus residue after swallowing scale
                                          score were compared. Rice gruel required a shorter oropharyngeal transit time and fewer number of
Citation: Kwak, S.; Choo, Y.J.; Choi,
K.T.; Chang, M.C. Safety and Efficacy
                                          swallowing per the given amount of food than regular instant rice porridge; however, no statistical
of Specially Designed                     difference was found in the vallecular and pyriform sinus residue after swallowing scale scores
Texture-Modified Foods for Patients       and the Penetration–Aspiration Scale scores. Bulgogi mousse required more swallowing and had
with Dysphagia Due to Brain               lower Penetration–Aspiration Scale scores than ground bulgogi; however, no significant difference
Disorders: A Prospective Study.           was found in the oropharyngeal transit time and the vallecular and pyriform sinus residue after
Healthcare 2021, 9, 728. https://         swallowing scale scores. The study foods were safe and efficacious compared to control foods usually
doi.org/10.3390/healthcare9060728         provided for patients with dysphagia from various brain disorders.

Academic Editor: Pedram Sendi             Keywords: dysphagia; texture-modified foods; dysphagia diet; brain disorders; texture analysis

Received: 14 May 2021
Accepted: 10 June 2021
Published: 13 June 2021
                                          1. Introduction
Publisher’s Note: MDPI stays neutral
                                               Texture is one of the four principal quality factors in food, along with its appearance,
with regard to jurisdictional claims in
                                          flavor and nutrition [1]. It is not a single property; it is a group of physical properties
published maps and institutional affil-   derived from the structure of the food. Adhesiveness, cohesiveness, firmness, fracturability,
iations.                                  hardness, springiness, viscosity and yield stress have been suggested to be the most
                                          significant components of texture in dysphagia diet and management [2]. Previous studies
                                          using kinematic analysis of dysphagia elucidated that bolus transit time and velocity are
                                          highly dependent on the patient’s medical conditions and food texture [3–7].
Copyright: © 2021 by the authors.
                                               Providing texture-modified food for patients with dysphagia has been accepted as
Licensee MDPI, Basel, Switzerland.
                                          a cornerstone of dysphagia treatment [2,8,9]. However, previous studies have reported
This article is an open access article
                                          poor adherence to texture-modified diets due to limited choice, unsatisfactory taste, lack
distributed under the terms and           of experience and knowledge for preparing texture-modified diet, higher cost and longer
conditions of the Creative Commons        time to prepare the foods as they require additional processing such as blending, grinding
Attribution (CC BY) license (https://     or chopping [10–12]. Poor adherence to texture-modified diet may lead to decreased oral
creativecommons.org/licenses/by/          intake, dehydration, increased risk of chest infection and malnutrition in patients with
4.0/).                                    dysphagia [13–15]. In addition, no specific food texture has been demonstrated to have

Healthcare 2021, 9, 728. https://doi.org/10.3390/healthcare9060728                                      https://www.mdpi.com/journal/healthcare
Healthcare 2021, 9, x                                                                                                                     2
Healthcare 2021, 9, 728                                                                                                                          2 of 9

                                                        dysphagia [13–15]. In addition, no specific food texture has been demonstrated to h
                                        clear, measurable   positive
                                                        clear,       impactpositive
                                                               measurable       on the swallowing
                                                                                          impact on the pattern   [16,17]. Even
                                                                                                             swallowing    pattern though     there
                                                                                                                                       [16,17].  Even arethough th
                                        several clinicalare
                                                         guidelines    for dysphagia
                                                             several clinical   guidelines diet,
                                                                                              formost   adopt diet,
                                                                                                   dysphagia     viscosity
                                                                                                                      mostcategory        boundaries,
                                                                                                                             adopt viscosity       category boun
                                        which are based     onwhich
                                                        ries,   consensus
                                                                     are basedrather    than evidence
                                                                                   on consensus     rather[16].
                                                                                                             than Therefore,
                                                                                                                   evidence [16].it isTherefore,
                                                                                                                                        important      toimportan
                                                                                                                                                    it is
                                        develop texture-modified      foods that canfoods
                                                        develop texture-modified          addressthatthe
                                                                                                       canaforementioned      issues.
                                                                                                            address the aforementioned          issues.
                                              In this study, In
                                                              wethis
                                                                   aimed
                                                                      study,to we
                                                                                evaluate
                                                                                    aimed the     safety and
                                                                                            to evaluate          efficacy
                                                                                                            the safety andofefficacy
                                                                                                                               specially     designeddesigned
                                                                                                                                         of specially
                                        texture-modified    foods (rice foods
                                                        ture-modified    gruel and(rice bulgogi
                                                                                         gruel and mousse)
                                                                                                      bulgogifor   patients
                                                                                                                mousse)   forwith    dysphagia
                                                                                                                              patients              that
                                                                                                                                          with dysphagia      that
                                        can be easily swallowed      while maintaining
                                                        be easily swallowed                    the unique
                                                                                  while maintaining        the taste of taste
                                                                                                                unique  foodsofby    adjusting
                                                                                                                                  foods            their their ha
                                                                                                                                           by adjusting
                                        hardness and adhesiveness       using videofluoroscopic
                                                        ness and adhesiveness                            swallowingswallowing
                                                                                      using videofluoroscopic           study (VFSS).       This(VFSS).
                                                                                                                                        study     study This st
                                        aimed to compareaimedthetoairway
                                                                   compare safety   measured
                                                                               the airway         by measured
                                                                                             safety   the Penetration–Aspiration           Scale (PAS) Scale (P
                                                                                                                   by the Penetration–Aspiration
                                        scores of the study
                                                        scoresand   control
                                                                of the  study foods   and compare
                                                                                 and control             the efficacy
                                                                                                 foods and    compareofthe theefficacy
                                                                                                                                study and      control
                                                                                                                                          of the  study and con
                                        foods using the foods  using the oropharyngeal
                                                           oropharyngeal                         transit time,
                                                                              transit time, number                number required
                                                                                                            of swallows     of swallows      required to elimin
                                                                                                                                         to eliminate
                                        food materialsfood
                                                         frommaterials    from the oropharyngeal
                                                               the oropharyngeal         space, and thespace,amountandofthe  amount
                                                                                                                          residue    in of
                                                                                                                                         theresidue
                                                                                                                                              pharynx  in the phar
                                                        after swallowing.
                                        after swallowing.

                                        2. Materials and  Methods and Methods
                                                       2. Materials
                                        2.1. Study Design
                                                       2.1. Study Design
                                             The study foodsThewere
                                                                  studyrice  gruel
                                                                          foods     andrice
                                                                                 were    bulgogi
                                                                                             gruel mousse   (Shinsegae
                                                                                                   and bulgogi     mousseFood     Inc., Seoul,
                                                                                                                            (Shinsegae    Food Inc., Se
                                        Korea). To evaluate  the   safety  and  efficacy  of the study  foods,   rice gruel
                                                       Korea). To evaluate the safety and efficacy of the study foods, rice  was   compared
                                                                                                                                     gruel was compa
                                        with a regular with
                                                       instant  rice porridge
                                                            a regular    instant widely   available
                                                                                  rice porridge      in the
                                                                                                 widely      marketinand
                                                                                                         available      thebulgogi
                                                                                                                            market andmousse
                                                                                                                                           bulgogi mou
                                        was compared was
                                                       withcompared
                                                             ground bulgogi,      which   normally  serves  as a  texture-modified    diet for
                                                                         with ground bulgogi, which normally serves as a texture-modified           die
                                        patients with dysphagia
                                                       patients within dysphagia
                                                                       our hospital    (Figure
                                                                                    in our     1). Since
                                                                                           hospital       it was
                                                                                                    (Figure        impractical
                                                                                                             1). Since           to compare
                                                                                                                       it was impractical   to compare
                                        the VFSS findings
                                                       VFSSoffindings
                                                               the study    andstudy
                                                                        of the   control
                                                                                       andfood  in different
                                                                                            control           patientspatients
                                                                                                    food in different    controlling   for po-for poten
                                                                                                                                  controlling
                                        tential confounding  factors,factors,
                                                       confounding      the study
                                                                                theand   control
                                                                                     study        foods were
                                                                                            and control  foodstested   in the same
                                                                                                                 were tested   in the patient.
                                                                                                                                       same patient. S
                                        Since we had two
                                                       we pairs
                                                          had twoof study   and
                                                                     pairs of    control
                                                                               study  andfoods,
                                                                                           controlthe patients
                                                                                                   foods,       were divided
                                                                                                          the patients          into two
                                                                                                                         were divided      dif-two diffe
                                                                                                                                         into
                                        ferent groups—the   rice   gruel  group    and  the bulgogi   mousse   group-    to avoid   excessive
                                                       groups—the rice gruel group and the bulgogi mousse group- to avoid excessive radia
                                        radiation exposure.
                                                       exposure.

                                FigureFigure
                                       1. Study
                                              1. and control
                                                  Study and foods.
                                                             control(A) rice gruel;
                                                                     foods.         (B) gruel;
                                                                              (A) rice  rice porridge;
                                                                                               (B) rice (C) bulgogi(C)
                                                                                                         porridge;  mousse; andmousse;
                                                                                                                       bulgogi  (D) ground
                                                                                                                                       andbulgogi.
                                                                                                                                           (D)
                                      ground bulgogi.

                                        2.2. Participants
                                              The inclusion criteria were as follows: (1) patients who were referred to the reha-
                                        bilitation department for VFSS; (2) patients who were diagnosed with stroke, traumatic
                                        brain injury, Parkinson’s disease, Alzheimer’s disease, brain tumor or hypoxic-ischemic
Healthcare 2021, 9, 728                                                                                            3 of 9

                          encephalopathy; (3) patients who could sit and maintain upright posture during VFSS;
                          (4) patients with alert mentality and sufficient cognitive function and could follow the
                          directions during VFSS; and (5) patients confirmed to have oropharyngeal dysphagia in the
                          VFSS. The exclusion criteria were as follows: (1) patients aged
Healthcare 2021, 9, 728                                                                                                            4 of 9

                                of the control food during the study period. Texture analyses were performed three times
                                for each food, and the mean values for each food were used to determine the UDF stage.
                                Statistical analysis was not performed to determine the changes in the texture of the food
                                after being mixed with Bonorex because the sample size was judged to be insufficient. All
                                texture analyses were performed at the Food Processing Laboratory of Sejong University.

                               Table 1. The Universal Design Foods guidelines for elderly people.

                                   Stage 1                     Stage 2                      Stage 3                    Stage 4
                                                            Able to smash               Able to smash             Able to swallow
       Classifications      Able to chew easily
                                                             with gums                   with tongue              without chewing
                          Contains hard and big        Contains hard and big       Contains soft and small
                                                                                                                 Hard to swallow if
  Standards of chewing     ingredients, a little        ingredients not easy         ingredients, easy
                                                                                                                 contains solid food
                            hard to swallow                 to swallow                  to swallow
                                                            Depends on              Have experience hard
        Standards of              Able to                                                                       Hard to swallow water
                                                          ingredients, hard          to swallow water or
        swallowing          swallow commonly                                                                     or liquid ingredients
                                                             to swallow               liquid ingredients
     Hardness (N/m2 )              5 × 105                     5 × 104                      2 × 104                    5 × 103
                          Reproduced from [20] via license: CC BY-NC 4.0. No changes were made to this table.

                                2.6. Standard Protocol Approvals, Registrations and Patient Consents
                                    This study was conducted in accordance with the Declaration of Helsinki and was
                               reviewed and approved by the Institutional Review Board of the University Hospital.
                               Written informed consent was obtained from all participants.

                                2.7. Statistical Analysis
                                     Data were analyzed using the Statistical Package for Social Sciences version 20.0 (IBM
                                Corp., Armonk, NY, USA). Demographic data of the study participants were compared
                                using the Mann-Whitney U test for age, Chi-squared test for gender and disease duration,
                                and Fisher’s exact test for diagnosis. Among the outcome measures, the oropharyngeal
                                transit time was compared using the paired t-test and the rest were compared using
                                the Wilcoxon signed-rank test. All tests were two-tailed and uncorrected for multiple
                                comparisons. Statistical significance was set at p < 0.05.

                                3. Results
                                     A total of 101 patients were enrolled in this study (50 and 51 in the rice gruel and
                               bulgogi mousse groups, respectively; Table 2). The mean patient age was 72 years in
                               the rice gruel group and 72.73 years in the bulgogi mousse group. Furthermore, 25 of
                               50 patients in the rice gruel group and 23 of 51 patients in the bulgogi mousse group had a
                               disease duration of ≥6 months. No significant difference was found in the demographic
                               data of the participants in the rice gruel and bulgogi mousse groups.
                                     According to the texture analysis of the study and control foods, rice gruel and rice
                               porridge were classified as UDF stage 4 (food can be swallowed without chewing) and
                               bulgogi mousse was classified as UDF stage 3 (food can be smashed with the tongue at
                               temperatures of 20 ◦ C–25 ◦ C and 40 ◦ C–50 ◦ C; Table 3). The UDF stage of each food was
                               maintained on mixing it with Bonorex 300, which was used as a contrast medium.
                                     After mixing with Bonorex 300, all the foods tested showed increased hardness at a
                               temperature of 20 ◦ C–25 ◦ C; however, rice gruel showed decreased hardness and bulgogi
                               mousse showed increased hardness at a temperature of 40 ◦ C–50 ◦ C. In terms of adhesive-
                               ness, all the foods tested showed decreased values after mixing with a contrast medium at
                               all temperatures.
Healthcare 2021, 9, 728                                                                                                                           5 of 9

                                     Table 2. Demographic data of the study participants.

                                                                                 Rice Gruel vs.          Bulgogi Mousse vs.
                                                                                                                                        p-Value
                                                                                 Rice Porridge            Ground Bulgogi
                                      Age (years) (mean ± SD)                     72.00 ± 15.17               72.73 ± 12.05             0.736 a
                                      Male: Female (n)                                23:27                       26:25                 0.482 b
                                      Diagnosis (n)                                                                                     0.350 c
                                        Ischemic stroke                                   23                       27
                                        Hemorrhagic stroke                                13                        6
                                        Alzheimer’s disease                               6                        12
                                        Parkinson’s disease                                4                        3
                                        Brain tumor                                        2                        1
                                        Hypoxic ischemic brain injury                     1                         0
                                        Traumatic brain injury                             1                        2
                                      Disease duration (n)                                                                              0.622 b
Healthcare 2021, 9, 728                                                                                                                              6 of 9

                                                    Table 4. Comparison of outcome measure.

                                                                                                  Bulgogi               Ground
                                      Rice Gruel a        Rice Porridge b        p-Value                                                   p-Value
                                                                                                  Mousse a             Bulgogi b
  Oropharyngeal transit time
                                      39.88 ± 18.40         61.08 ± 28.59
Healthcare 2021, 9, 728                                                                                                    7 of 9

                          lower PAS score, could result from differences in the texture of the ground bulgogi and
                          bulgogi mousse. It appears that the viscosity of ground bulgogi was lower than that of
                          bulgogi mousse, which is compatible with the results of previous studies that reported
                          that boluses with lower viscosity are more difficult to swallow safely than boluses with
                          higher viscosity [22,23]. However, objective texture analysis for ground bulgogi was not
                          performed in this study; thus, further studies are needed to elucidate its association. It
                          should also be noted that despite the statistical significance, the mean difference in PAS
                          scores might not be significant in the clinical setting.
                                Several previous studies have identified the beneficial effect of high shear viscosity in
                          reducing the risk of aspiration during swallowing. It is assumed that high-viscosity boluses
                          are transported more slowly than low-viscosity boluses, thus allowing more time for the
                          oropharyngeal mechanism to secure the airways until the bolus enters the esophagus [9].
                          Therefore, the nutritional management of patients with dysphagia is based on increasing
                          the viscosity to a certain range that is considered safe for swallowing. However, very thick
                          foods are poorly accepted by patients, and high-viscosity foods may result in an increase in
                          residues after swallowing, reduction of palatability and increased risk of dehydration [24,25].
                          Therefore, it is important for clinicians to understand the physical properties of foods and
                          their relation to dysphagia and be more specific in prescribing texture-modified diets for
                          patients with dysphagia.
                                However, the assessment and application of texture modification is subjective in
                          clinical settings; the preparation as well as the rheological evaluation and administration
                          of thickened foods to patients are universally subjective and a wide range of viscous
                          properties are recommended for the same level of dysphagia [26,27]. In addition, despite
                          the established knowledge on the close connection between dysphagia and rheological
                          properties of food bolus, knowledge has not been incorporated into the national guidelines
                          for the dietary management of dysphagia, such as the National Dysphagia Diet Task Force
                          (2002) of the American Dietetic Association [28] or the British Dietetic Association (2009) in
                          the National Description for Texture Modification in Adults [29]. However, attempts have
                          been made to establish an international terminology for texture-modified foods used in
                          dysphagia management [8,30,31].
                                The results of this study are meaningful because to the best of our knowledge, this
                          is the first study to evaluate the safety and efficacy of specially designed dysphagia food
                          in patients with brain disorders using VFSS. Previous studies have focused mainly on the
                          nutritional state of patients with dysphagia [12,31–33], but limited information is available
                          regarding the safety and efficacy of swallowing foods with different physical properties
                          other than viscosity using VFSS.

                          Study Limitations
                               First, the lack of randomization of the sequence of study and control foods is a major
                          limitation of this study. Due to the limited staffing, blinding for the sequence was not
                          possible, and this could lead to bias. Second, texture analyses of ground bulgogi and
                          rice porridge mixed with Bonorex at a temperature of 40 ◦ C–50 ◦ C were not performed.
                          In addition, the ease of preparation (compared to conventional texture-modified foods
                          prepared at home), adherence to the prescribed diet, patient satisfaction and long-term
                          outcomes such as nutritional state or frequency of chest infection, were not included in the
                          current study.

                          5. Conclusions
                               In conclusion, the specially designed texture-modified foods—rice gruel and bulgogi
                          mousse—were found to be safe and efficacious for patients with dysphagia and various
                          brain disorders. Therefore, practical application of these foods is warranted.

                          Author Contributions: Conceptualization, S.K. and M.C.C.; methodology, S.K. and M.C.C.; software,
                          S.K. and M.C.C.; validation, S.K. and M.C.C.; formal analysis, Y.J.C. and K.T.C.; investigation, Y.J.C.
                          and K.T.C.; resources, Y.J.C. and K.T.C.; data curation, Y.J.C. and K.T.C.; writing—original draft
Healthcare 2021, 9, 728                                                                                                                  8 of 9

                                   preparation, S.K., Y.J.C., K.T.C. and M.C.C.; writing—review and editing, S.K., Y.J.C., K.T.C. and
                                   M.C.C.; visualization, S.K., Y.J.C., K.T.C. and M.C.C.; supervision, M.C.C. All authors have read and
                                   agreed to the published version of the manuscript.
                                   Funding: This study was supported by Shinsegae Food Inc., Korea; and a National Research Founda-
                                   tion of Korea Grant funded by the Korean government (grant number NRF-2019M3E5D1A02068106).
                                   Institutional Review Board Statement: The study was conducted according to the guidelines of the
                                   Declaration of Helsinki and approved by the Institutional Review Board of Yeungnam University
                                   Hospital (2019-02-022-001).
                                   Informed Consent Statement: Informed consent was obtained from all subjects involved in the study.
                                   Data Availability Statement: The data presented in this study are available on request from the
                                   corresponding author.
                                   Conflicts of Interest: The authors declare no conflict of interest. The funder had no involvement in
                                   study design, methods, subject recruitment, data collections, analysis and preparation of paper. In
                                   addition, the funder was not involved in the decision to submit the article for publication.

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